BD ChloraPrep CLear skin antiseptic recalled for lack of sterility assurance
What this means
BD ChloraPrep CLear, a chlorhexidine-based skin antiseptic solution in single-use applicators, was distributed without proper sterilization. Unsterilized applicators intended for further processing were mistakenly sent to customers outside the intended distribution channel. This affects 18,000 units across multiple lot numbers distributed nationwide.
- Check if you have ChloraPrep CLear applicators from the affected lots (4088933, 4177711, 4195438, 5051114, 5070540, 5106254, 5141607, or 5196494).
- Do not use applicators from these lots for patient care or medical procedures.
- Contact your supplier or BD customer service with lot numbers and quantities for instructions on return or replacement.
The agency's original wording
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2026More CareFusion recalls
- FDA-Drug2026-07-22BD ChloraPrep Clear skin antiseptic recalled for potential sterility packaging defect
- FDA-Drug2026-07-08BD ChloraPrep Clear skin antiseptic recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Scrub Teal recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange skin antiseptic recalled for lack of sterility assurance
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